Class 2 Device Recall ACUSON AcuNav Volume ICE Catheter

• Date Initiated by Firm: May 22, 2020
• Create Date: October 08, 2020
• Recall Status: Terminated on October 15, 2021
• Recall Number: Z-0090-2021
• Recall Event ID: 85807
• 510(K)Number: K173618
• Product Classification: Catheter, ultrasound, intravascular - Product Code OBJ
• Product: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
• Code Information: Model Number: 10855958 GTIN: 40568690042666 Serial Numbers: XR000665 XR000035 XR000405 XR000713 XR000714 XR000717 XR000720 XR000492 XR000493 XR000623 XR000692 XR000693 XR000427 XR000428 XR000429 XR000430 XR000431 XR000432 XR000434 XR000435 XR000437 XR000438 XR000648 XR000656 XR000658 XR000661 XR000568 XR000605 XR000606 XR000607 XR000608 XR000002 XR000596 XR000597 XR000600 XR000601 XR000694 XR000695 XR000587 XR000588 XR000120 XR000131 XR000653 XR000654 XR000698 XR000473 XR000474 XR000475 XR000480 XR000372 XR000373 XR000374 XR000380 XR000011 XR000168 XR000226 XR000227 XR000394 XR000479 XR000517 XR000518 XR000598 XR000602 XR000603 XR000007 XR000008 XR000012 XR000013 XR000018 XR000019 XR000022 XR000023 XR000028 XR000260 XR000265 XR000756 XR000759 XR000029 XR000609 XR000610 XR000486 XR000487 XR000488 XR000489 XR000213 XR000214 XR000216 XR000218 XR000220 XR000221 XR000222 XR000223 XR000224 XR000225 XR000420 XR000421 XR000424 XR000425 XR000442 XR000443 XR000444 XR000445 XR000446 XR000447 XR000448 XR000449 XR000450 XR000451 XR000452 XR000453 XR000454 XR000455 XR000456 XR000457 XR000458 XR000459 XR000460 XR000461 XR000462 XR000463 XR000464 XR000465 XR000466 XR000467 XR000494 XR000495 XR000496 XR000497 XR000500 XR000502 XR000503 XR000504 XR000505 XR000506 XR000507 XR000509 XR000510 XR000511 XR000512 XR000513 XR000514 XR000544 XR000548 XR000551 XR000555 XR000556 XR000559 XR000560 XR000662 XR000666 XR000741 XR000746 XR000747 XR000748 XR000696 XR000697 XR000707 XR000711 XR000490 XR000491 XR000524 XR000525 XR000527 XR000530 XR000369 XR000381 XR000390 XR000769 XR000770 XR000705 XR000709 XR000710 XR000379 XR000385 XR000126 XR000132 XR000133 XR000134 XR000140 XR000141 XR000142 XR000144 XR000422 XR000423 XR000440 XR000441 XR000468 XR000469 XR000470 XR000471 XR000472 XR000477 XR000478 XR000498 XR000499 XR000515 XR000523 XR000526 XR000575 XR000576 XR000593 XR000595 XR000621 XR000622 XR000641 XR000642 XR000663 XR000669 XR000718 XR000719 XR000128 XR000130 XR000148 XR000519 XR000520 XR000521 XR000522 XR000700 XR000701 XR000704 XR000706 XR000708 XR000715 XR000651 XR000657 XR000589 XR000590 XR000591 XR000592 XR000416 XR000417 XR000418 XR000419 XR000721 XR000723 XR000724 XR000726 XR000727 XR000728 XR000736 XR000737 XR000366 XR000629 XR000630 XR000631 XR000632 XR000407 XR000408 XR000616 XR000617 XR000702 XR000703 XR000755 XR000760 XR000212 XR000215 XR000041 XR000045 XR000773 XR000774 XR000643 XR000644 XR000566 XR000567 XR000569 XR000570 XR000742 XR000743 XR000044 XR000048 XR000121 XR000123 XR000135 XR000136 XR000021 XR000049 XR000767 XR000768 XR000771 XR000772 XR000577 XR000578 XR000581 XR000582 XR000583 XR000584 XR000585 XR000586 XR000009 XR000016 XR000026 XR000027 XR000031 XR000633 XR000635 XR000531 XR000532 XR000534 XR000535 XR000536 XR000537 XR000538 XR000539 XR000540 XR000541 XR000542 XR000543 XR000659 XR000660 XR000664 XR000670 XR000611 XR000612 XR000615 XR000766 XR000124 XR000137 XR000139 XR000145 XR000147 XR000160 XR000171 XR000172 XR000174 XR000176 XR000177 XR000180 XR000571 XR000572 XR000573 XR000574 XR000579 XR000580
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 22010 SE 51st St; Issaquah WA 98029-7298
• For Additional Information Contact: Kristen Clyman; 650-417-8185
• Manufacturer Reason for Recall: Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
• FDA Determined Cause: Under Investigation by firm
• Action: On 05/22/2020, the firm notified customers via telephone of the recall and send on 05/26/2020 an email with an attached "URGENT SAFETY ADVISORY NOTIFICATION" Letter inform customer that the Recalling Firm has received reports of left atrial perforations and Atrioventricular Node block occurring while using the affected product. The customer notification instructs customers to: -Immediately stop performing procedures using the affected catheters and segregate the product. -All remaining affected inventory in their possession will be collected. The following steps outline the sequence of this process: -Users of the device have been contacted personally by the Recalling Firm's Ultrasound Management; -Customers will be reimbursed for their remaining, unused inventory; -A Clinical Specialist will call to schedule a time to document and retrieve inventory. OR Customers may ship the remaining inventory to the following address. Customers that wish to ship remaining inventory, should inform the Clinical Specialist of this when they are contacted. Address to return products: Siemens Healthineers Ultrasound Attention: Kristen Clyman 22010 S.E. 51st Street Issaquah, WA 98029 Customer are also instructed to: -Complete the Recall Acknowledgement Form and return to the Recalling Firm as soon as possible and email to Kristen.Clyman@siemens-healthineers.com, and -Ensure that all users of the affected products within your organization and others who may need to be informed receive the safety relevant information provided with the notice and take the actions specified therein.
• Distribution: U.S.: AZ, CA, FL, GA, IL, KY, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TX, VA, WA and WV. O.U.S; Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OBJ